1. Field of the Invention
This invention relates generally to the field of medical devices and, more particularly to a breathing tube support device having a flexible support arm that is axially extendable and collapsible and capable of assuming a bent or curved configuration with a mounting base at a bottom end for attachment to a patient or support surface and a breathing tube holder member at a top end thereof for holding, supporting, and selectively positioning conventional flexible tubes or hoses of a breathing circuit during provision of anesthesia, assisted and artificial ventilation, and/or spontaneous ventilation.
2. Background Art
21 CFR §868.5240 (a) defines an “anesthesia breathing circuit” as a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece. 21 CFR §868.5280 (a) defines a “breathing tube support” as a device that is intended to support and anchor a patient's breathing tube(s).
Breathing circuits have been used in the anesthesia field for many years to provide a vehicle for transferring anesthesia gas from an anesthesia machine to a patient, and to transfer exhaled gas from the patient to the anesthesia machine. Currently, two primary types of breathing circuits are used. The first type is known as a “dual-limb” circuit. Such a device includes an expiratory tube and an inspiratory tube formed of flexible corrugated tubing that are usually connected to a Y-piece connector. The Y-piece is then coupled, at its patient end, to an endotracheal tube or an anesthesia face mask. The machine end of the inspiratory tube is coupled to the inspiratory port of either an anesthesia machine, or to a carbon dioxide absorber that is attached to an anesthesia machine. The machine end of the expiratory tube is attached to either the anesthesia machine, or to a carbon dioxide absorber attached to an anesthesia machine.
The other type of circuit is a “unilimb” circuit. A unilimb breathing circuit includes an expiratory tube and an inspiratory tube formed of flexible corrugated tubing, that are coupled in a coaxial relation, one inside the other. Usually, the inspiratory tube is disposed within the interior of the expiratory tube. A patient end connector is provided for coupling the patient end of the unilimb breathing circuit to either an endotracheal tube or an anesthesia face mask. The machine end of the unilimb circuit contains a coupler having an inspiratory coupler and a separate, expiratory coupler. The inspiratory coupler is coupled to the inspiratory port of a carbon dioxide absorber or anesthesia machine, and the expiratory coupler is coupled to the expiratory port of the anesthesia machine or carbon dioxide absorber. The inspiratory coupler handles gas from the inspiratory tube, and the expiratory coupler end handles gas from the expiratory coupler.
Both the inspiratory and expiratory tubes function in a similar manner. Anesthesia gas and oxygen are directed into the inspiratory tube, where the gases travel from the machine end of the inspiratory tube to the patient end. The gases are then inhaled by the patient. When the patient exhales, his or her expiratory gases flow into the expiratory tube, which conveys the gases back to the carbon dioxide absorber. The conventional breathing circuit may also include controls for assisting or controlling breathing, exhaled volume indicators, alarm systems, positive end expiratory pressure (“PEEP”) valves, pressure indicators, gas concentration monitors, flow indicators, heated humidifiers for warming and humidifying the breathing gas.
The flexible corrugated breathing tubes of the breathing circuit extend from between the endotracheal tube of an intubated patient or an anesthesia face mask attached to the patient and the anesthesia machine, carbon dioxide absorber, or other apparatus which is typically disposed a distance away from the patient. It is important to insure that there are no kinks or bends in the breathing tubes.
The endotracheal tube placed in a patient's larynx and connected to the breathing circuit can cause more injury than is generally appreciated. Even brief incubation for surgical procedures may cause surface damage. Damage may occur wherever the endotracheal tube comes in contact with tissue although the larynx and trachea are particularly at risk. A minor area of insult may be followed by spontaneous resolution, or a devastating sequence of events leading to irreversible injury. During the presence of the endotracheal tube in the larynx, significant variables can affect the degree of insult, including tube size and shape, excessive cuff pressure, stylet trauma, infection, systemic disease, laryngopharyngeal reflux and the position of the endotracheal tube.
Movement of the endotracheal tube caused by manipulation of the surgeon during anesthesia, such as in a sitting shoulder operation, can cause shearing forces that add to the abrasion of the mucosa. Research studies have shown that excessive movement of the tube during assisted ventilation to further extend the damage caused by the endotracheal tube cuff. The tube position may be shifted during repositioning of the patient or by the operating surgeon. The endotracheal tube thus may be advanced against the tracheal wall or into the main bronchi or withdrawn into the larynx or hypopharynx. Other authors cite the vulnerability of the recurrent laryngeal nerve to pressure damage including from excessive stretching of the neck, among other causes, and that excessive head movement increases the pressure and shearing forces to which the arytenoids are exposed which further aggravates the inherent mucosal injury.
Some anesthesia providers do not support the breathing circuit tubing at all and allow the endotracheal tube and the breathing circuit tubing to dangle from the vocal cords. To minimize damage caused by the endotracheal tube, in a sitting operation, many anesthesia providers firmly affix the endotracheal tube to the patient and support the anesthesia breathing circuit tubes with a fixed tube tree, which is disposed on the unoperative side of the patient to minimize angulation and movement of the tube. A fixed tube tree typically has a flat horizontal leg and a flat vertical leg perpendicular thereto wherein the horizontal leg attaches to a support surface or slides under a bed or stretcher mattress or a pillow, and the outer end of the vertical legs are provided with cutout portions that hold the breathing circuit tubes.
However, when a surgeon pulls or manipulates a patient's shoulder, for example, the endotracheal tube and breathing circuit tubes secured on the tree will often pull on the larynx. The breathing circuit tubes secured on the tree will also exert a pulling force because the tree is typically disposed a distance from the patient. Head movement of the patient can also alter the position of the breathing circuit tubes.
There are several commercially available products and patents directed toward supports of various constructions for supporting breathing tubes and other medical tubing having various mounting arrangements.
SunMed, of Largo, Fla., manufactures several generally L-shaped breathing tube supports known a “Tube Tree” which have a flat horizontal leg and a flat vertical leg perpendicular thereto wherein the horizontal leg slides under a bed or stretcher mattress or a pillow, and the outer ends and lateral sides of the horizontal and vertical legs are provided with cutout portions that hold tubes of various diameters.
Bay-Medical, of Largo, Fla., markets an L-shaped breathing tube supports known as the “Derbyshire Tube Support” which has a flat horizontal leg and a flat vertical leg perpendicular thereto wherein the horizontal leg slides under a bed or stretcher mattress or a pillow, and the outer end of the vertical leg is provided with cutout portions that hold tubes of various diameters.
Trademark Medical, of Largo, Fla., markets an L-shaped Airway Circuit Holder known as an “Adjustable Tube Tree” which has a flat horizontal leg and a flat vertical leg perpendicular thereto with another flat vertical member pivotally and adjustably connected thereto which has cutout portions at its outer end that hold tubes of various diameters wherein the horizontal leg slides under a surgical pad or bed mattress, and the flat vertical member can be adjusted vertically and in a 180° arc.
Baitella AG. of Zurich, Switzerland, manufactures a FISSO® holding system which includes a pair of articulating arms connected by a central tightening unit which are positionable relative to one another and having ball and socket connections at their outer ends, one end of one arm is provided an operating table rail connector and the other arm is provided with a tube holder for holding breathing circuits, pressure transducers, endoscopes, instruments and other medical components and devices. The central tightening unit allows the arms and all joints to be fixed in place with a single knob.
JITTO International, of London, U.K., manufactures several breathing tube circuit holders or hangers under the brand name TANGO™ and ERGO™ Circuit Hangers that have articulating arms mounted in either of a wall mount cradle, pole clamp, rail clamp or table clamp with a flexible arm at the outer end thereof which can be adjusted to variable rotational angles and a multiple tube holder at the outer end of the flexible arm for supporting breathing circuit tubes of different diameters.
Gunerman, U.S. Published Patent Application 2007/0170318, assigned to Intersurgical Incorporated, of Liverpool, N.Y., discloses a breathing tube support arm for supporting a patient's breathing tube(s) which includes a system of hollow, interlocking, articulating beads, and a system of stiffeners inside of the hollow beads, the stiffeners being of three different stiffnesses. The support arm has a universal rail mounting block at the base end, and a tube holder or connector at a top end for receiving the breathing tube(s). Intersurgical Incorporated also markets a version known as the “Knucklehead Mini” which has a flat or L-shaped base member.
Newkirk et al, U.S. Pat. No. 7,766,289 discloses a line management device for supporting one or more patient care lines adapted to extend from a patient supported on a bed. The device includes a flexible support body, a coupler at one end to couple the support body to the bed, and a line manager at the other end, the line manager including a body, a plurality of upwardly extending fingers extending from the body, at least one of the upwardly extending fingers and a plurality of channels located between the upwardly extending fingers.
Van Hooser, U.S. Pat. No. 7,124,755 discloses a support arm for use in a respiratory circuit that includes a plurality of arm segments movably connected with one another such that the arm segments are adjustable with respect to another. At least one inflatable bladder is operably disposed at a point of connection between at least two of the arm segments. The arm segments are locked into position with respect to one another upon inflation of the bladder. The arm segments are released and positionable with respect to one another upon deflation of the bladder. Also, a respiratory support member is attached to one of the arm segments. The respiratory support member is configured for engaging the respiratory circuit to support the respiratory circuit.
Schattner et al, U.S. Pat. No. 6,375,017 discloses a tubing organizer apparatus which includes a body member that extends radially outwardly from a central axis. The body member has opposite surfaces and a peripheral wall that is disposed between the opposite surfaces. The peripheral wall includes a plurality of exterior wall segments facing outwardly relative to the central axis and a plurality of interior wall segments connected to the exterior wall segments that are configured to form a corresponding plurality of notches extending inwardly between consecutive ones of the exterior wall segments and into the body member relative to the central axis. The tubing organizer apparatus may also include a generally L-shaped support structure for rotatably mounting the body member thereto, and may include a plurality of gates, each gate spanning across a respective notch for releasably retaining one or more lengths of pliable tubing within the respective notch.
Allard et al, U.S. Pat. No. 4,023,757 discloses a holder for removable attachment to a hospital bed for releasably holding control devices operated by the patient. The holder includes an elongated flexible and positionable member attachable at one end to the frame of the bed and having a head at the other end formed with slotted openings for receiving electrical and other types of cords or tubular hoses.
Abel, U.S. Pat. No. 5,163,914 discloses a respirator hose support pad for tracheostomy patients that has a hook and loop fastener structure on the central bottom surface for releasable attachment to a patient's garment in the upper central chest area. The terminal oppositely disposed ends of the pad each have an extending flange that serve as handles. The pad additionally has a detachable flexible belt on the top surface for adjustable loose securement of the respirator hose onto the top of the pad such that the hose is loosely retained between the pad and belt, and may slide back and forth across the pad to prevent excessive pulling on the tracheostomy tube as the patient moves. The interior of the pad contains a compressible and somewhat resilient padding material to dampen the irritating and painful effect on the patient's tracheostomy of the respirator hose vibrations and jerking movements caused by the intermittent positive pressure introduction of gasses into the patient. The pad is additionally utilized to help maintain the respirator hose angling downhill in order to direct fluids which naturally condense in the respirator hose away from the patient's tracheostomy tube and lungs.
Warrick, U.S. Pat. No. 5,672,159 discloses a medical tubing support which includes a harness strap that is attached around the body of a patient, a detachable pad selectively attached to the harness strap, and at least one adjustable strap pivotally attached to the detachable pad which secures ventilation circuit tubing on the detachable pad. The first end of the adjustable strap is attached to a rivet located in the center of the detachable pad to allow pivotal movement, and the second end of the adjustable strap is wrapped over an object such as ventilation circuit tubes to hold the tubes on the detachable pad. Hook and loop surfaces disposed between the detachable pad and the adjustable strap enables the adjustable strap to be selectively fixed in position on the detachable pad, and hook and loop surfaces provided between the detachable pad and the topside of the harness allows the detachable pad to be selectively placed on the topside of the harness.
Rennie, U.S. Pat. No. 4,018,221 discloses a support for anesthetic gas delivery hoses and endotracheal tubes comprising an enlongated flexible strap with opposite sides of opposite ends of the strap provided with strips of hook and loop fasteners secured thereto. One of the fastener strips is spaced from the corresponding terminal end of the strap and that terminal end has a thick somewhat flexible and deformable pad secured thereto on the same side as the adjacent fastener strip. The strap may be encircled about a portion of a patient's body, such as the patient's head, and the opposite end portions of the strap may be overlapped with the fastener strips engaged with each other securing the strap about the patient's head. The overlapped portions of the pad and opposite end portion of the strap define opposing friction surfaces between which anesthesia hoses, etc., may be clamped for stationary support from the patient's head.
Watson, U.S. Pat. No. 4,821,736 discloses a head-mounted device for supporting breathing circuit tubes and CO2 sensor which positions the sensor and breathing tubes adjacent the centerline of the forehead and above the head. The device includes a cushion positionable on the forehead, a rigid plate positionable over the cushion and having first and second portions, a band wrapped around the outer surfaces of the first plate portion and cushion and around the head, and connecting means on the second plate portion and sensor for attaching the sensor and breathing circuit tubes adjacent the centerline of the forehead and above the head. The plate counterbalances the weight of the sensor and provides a thermal shield protecting the patient from heat generated by the sensor.
Russo, U.S. Pat. No. 6,419,660 discloses a tube holder which includes a base for attachment to a surface, for example, a patient's skin, and a tab for securing the tube to the base. In one embodiment, the tube holder includes a first layer having first and second sides and first and second sections, and a second layer having first and second sides and first and second sections. The first sides of the first and second layers are attached to one another in the first sections of the first and second layers, the second sections of the first sides of the first and second layers are unattached to one another, and the first sections of the first and second layers form the tab and the second sections form the base. The tube holder also includes a third layer attached to the second side of the first layer for receiving a tube.
Bowen et al, U.S. Pat. No. 5,147,322 discloses a medical appliance securing device for laterally and longitudinally securing generally tubular members having various diameters to any desired location on the surface of a patient's skin or other support. The appliance comprises an anchoring patch having one surface coated with adhesive for bonding the device to a patient's skin or some other support, and a retaining tab connected to the anchoring patch that contains an aperture such that the retaining tab may be wrapped around the circumference of the tubular member, inserted through the aperture, and firmly secured to the anchoring patch through the use of fastening means.